Sir Michael Rawlins: the profession needs to adapt and respond

Sir Michael Rawlins, chair of NICE, addressed a packed audience of regulatory affairs professionals in the inaugural TOPRA Annual Lecture.

Speaking ahead of this year's TOPRA Awards for Excellence in Regulatory Affairs at London's Radisson Blu Portman Square on 28 November, Sir Michael asked the question ’Is the regulatory profession fit for the future?’.

His answer was that he didn’t know, but that the profession must adapt to the rapidly changing regulatory environment and respond to healthcare innovation.

The audience had no need to be disappointed by Sir Michael’s opening response to the question as he clearly set out the challenges which the pharmaceutical industry will face over the next decade.

He then put the challenges into the historical context of the debate within science between the deductive approach, which tests a theory, and the inductive approach, which tests a pattern identified by observation. This set the groundwork for his message that regulators and industry have to re-evaluate how they test and use clinical data to support decisions on marketing authorisations and benefit-risk decisions.

Sir Michael argued for a major reappraisal of the hierarchy of evidence and the need for flexibility to use observational data, historical control studies and to introduce real-world studies. He also stressed the opportunities offered by the use of Bayesian statistics and the need for pilot projects to take forward adaptive licensing.

He concluded by stressing the need and the opportunity for the regulatory science profession to seize and lead the debate – a challenge that the audience seemed willing to take on.

Thanking Sir Michael for his insightful lecture, Dr David Jefferys, Past President of TOPRA, said the lecture was ’a timely wake up call for all engaged in medicines regulation that the profession would take forward’.

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